Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366314
Status:
TERMINATED
Last Update Posted:
2007-06-13
First Post:
2006-08-17
Brief Title:
Frequency of Accessing Central Lines for Blood Samples
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Frequency of Accessing Central Lines for Blood Samples and Medication Administration A Comparison Between CICU PICU and NICU
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to quantify and analyze the line accesses for each of the 3 participating ICUs
The hypothesis is that the CICU will have a significantly higher number of line accesses than the other units Analyzing the data will assist the researchers in identifying best practices and ultimately reduce the BSI rate in the CICU
The hypothesis is that the CICU will have a significantly higher number of line accesses than the other units Analyzing the data will assist the researchers in identifying best practices and ultimately reduce the BSI rate in the CICU
Detailed Description:
The CICU is participating in the system wide initiative to decrease blood stream infections BSIs In January 2006 the BSI rate in the CICU at Childrens Egleston peaked at 182 rate of infections per 1000 catheter days The BSI Bundles processes of care were rolled out on January 16 2006 according to CHCA guidelines Child Health Corporation of America The Childrens February BSI rate remained high at 163 despite the bundle implementation The target goal is to maintain a rate below 37 which was realized only in March with a rate of 34 Subsequent months were 54 and 49 See attached graph
A separate research study is currently being conducted by Nicole Jarrell in collaboration with Drs Kevin Maher and Agustin Rubio to determine risk factors for contracting a BSI by analyzing the past 200 infections positive blood cultures in the CICU Preliminary findings in this study indicate a particularly high risk patient population those with delayed sternal closures open chests
Results from this study indicate that of the 95 patients January 2004-February 2006 with open chests 28 developed BSIs 295 This was compared to neonates undergoing cardiac bypass surgery with closed chests This patient population had a significantly lower BSI rate at 91 n9 of 99 The largest subset of patients in these groups are the neonates with HLHS Hypoplastic Left Heart Syndrome undergoing the Norwood procedure Upon reviewing all HLHSNorwood patients those with open chests N40 have a 325 infection rate compared to the closed chests N20 at 20
Multiple risk factors are assumed to contribute to the high risk and rate of infection in the CICU patient population One risk that has been substantiated during a quality improvement project conducted in the CICU is related to accessing lines The number of times that the patients central and arterial lines are entered for blood sampling and medication administration was analyzed utilizing chart review of a small sample group of CICU patients n29 For these 29 patients their lines were accessed 5476 times during their CICU LOS length of stay The average CICU LOS was 74 days Of the 29 patients 3 had open chests with an average duration of 7 days open
The average times the line was accessed for the duration of LOS was 189 times at a rate of 13 per shift When the patient LOS was 5 days n11 with an average LOS of 16 days the total average increased to 455 times during the LOS but per shift averages remained the same at 13
This preliminary data indicates that the frequency of accessing lines in the CICU is a significant risk factor for cardiac ICU patients for acquiring a BSI
Benchmarking of BSI rates against the other ICUs PICU and NICU at Egleston indicate the CICU has the highest infection rate of the ICUs First quarter mean rates are as follows
CICU129
NICU29
PICU0
Differences in demographics of high risk patients are a factor in the differentiation between the units however there are also known specific differences in practice Further analysis of specific practices related to minimizing infection risks are necessary to determine the best practices This includes the frequency and specific reasons for accessing patients central lines which is the focus of this study
One primary difference in practice is related to the use of additional respiratory monitoring which allows for reduction in the number of blood samples for blood gas analysis Another significant difference is in the utilization of medication drips instead of bolus medications thus reducing the number of times the line is entered to administer medications Although these practice differences are known the actual impact on the patient by reducing the number of accesses to the lines and therefore reducing the risk of BSI is unknown
A separate research study is currently being conducted by Nicole Jarrell in collaboration with Drs Kevin Maher and Agustin Rubio to determine risk factors for contracting a BSI by analyzing the past 200 infections positive blood cultures in the CICU Preliminary findings in this study indicate a particularly high risk patient population those with delayed sternal closures open chests
Results from this study indicate that of the 95 patients January 2004-February 2006 with open chests 28 developed BSIs 295 This was compared to neonates undergoing cardiac bypass surgery with closed chests This patient population had a significantly lower BSI rate at 91 n9 of 99 The largest subset of patients in these groups are the neonates with HLHS Hypoplastic Left Heart Syndrome undergoing the Norwood procedure Upon reviewing all HLHSNorwood patients those with open chests N40 have a 325 infection rate compared to the closed chests N20 at 20
Multiple risk factors are assumed to contribute to the high risk and rate of infection in the CICU patient population One risk that has been substantiated during a quality improvement project conducted in the CICU is related to accessing lines The number of times that the patients central and arterial lines are entered for blood sampling and medication administration was analyzed utilizing chart review of a small sample group of CICU patients n29 For these 29 patients their lines were accessed 5476 times during their CICU LOS length of stay The average CICU LOS was 74 days Of the 29 patients 3 had open chests with an average duration of 7 days open
The average times the line was accessed for the duration of LOS was 189 times at a rate of 13 per shift When the patient LOS was 5 days n11 with an average LOS of 16 days the total average increased to 455 times during the LOS but per shift averages remained the same at 13
This preliminary data indicates that the frequency of accessing lines in the CICU is a significant risk factor for cardiac ICU patients for acquiring a BSI
Benchmarking of BSI rates against the other ICUs PICU and NICU at Egleston indicate the CICU has the highest infection rate of the ICUs First quarter mean rates are as follows
CICU129
NICU29
PICU0
Differences in demographics of high risk patients are a factor in the differentiation between the units however there are also known specific differences in practice Further analysis of specific practices related to minimizing infection risks are necessary to determine the best practices This includes the frequency and specific reasons for accessing patients central lines which is the focus of this study
One primary difference in practice is related to the use of additional respiratory monitoring which allows for reduction in the number of blood samples for blood gas analysis Another significant difference is in the utilization of medication drips instead of bolus medications thus reducing the number of times the line is entered to administer medications Although these practice differences are known the actual impact on the patient by reducing the number of accesses to the lines and therefore reducing the risk of BSI is unknown
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None